PENTAX VIDEO DUODENOSCOPE ED-3490TK

Transcription

1 Only For the Americas INSTRUCTIONS FOR USE (REPROCESSING) PENTAX VIDEO DUODENOSCOPE ED-3490TK This instructions for use describes the recommended procedures for the reprocessing and maintenance of the duodenoscope after its use. For the inspection and directions for use, please refer to the separate operation instructions for use.

2 Intended Use The ED-3490TK, Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations. Sterility Statement The endoscope identified in this IFU is a reusable semicritical device. Since the endoscope is packaged non-sterile, it must be cleaned and high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, it must be subjected to appropriate cleaning and either high-level disinfection or sterilization processes. Contraindication Please consult regional and national health authority recommendations and requirements regarding protocols to follow in order to reprocess and/or destroy endoscopes that will be used or have been determined to have been used (post procedure) on patients afflicted with Creutzfeldt-Jacob Disease (CJD or vcjd). Notes Read this IFU before operating, and save this book for future reference. Failure to read and thoroughly understand the information presented in this IFU, as well as those developed for ancillary endoscopic equipment and accessories, may result in serious injury including infection by cross contamination of the patient and/or user. Furthermore, failure to follow the instructions in this IFU and the companion IFU may result in damage to, and/or malfunction of, this equipment. This IFU describes the recommended procedures for the reprocessing and maintenance of the equipment after its use. It is the responsibility of each medical facility to ensure that only well-educated and appropriately trained personnel, who are competent and knowledgeable about the endoscopic equipment, antimicrobial agents/processes, and hospital infection control protocol are involved in the reprocessing of these medical devices. Current infection control guidelines require that G.I. endoscopes and other semi-critical medical devices that normally come into contact with intact mucus membranes, such as in the gastrointestinal tract, must at least be cleaned and high-level disinfected before patient use. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to each clinical use. It must be recognized that infection control practices involve many complex and often controversial issues which are constantly evolving. PENTAX strongly recommends that user remain informed of the latest federal and local regulations, and it encourages users to follow infection control guidelines developed by various organizations for health care professionals. If you have any questions regarding the information in this IFU or concerns pertaining to the safety and/or use of this equipment, please contact your local PENTAX representative. Conventions Throughout this IFU, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided; WARNING : could result in serious adverse reactions and potential safety hazards. CAUTION : may result in adverse reactions for safe and effective use of the device. NOTE : may result in property-damage. Also advises owner/operator about important information on the use of this equipment. Prescription Statement Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional.

3 Symbols on Marking Symboles distinctifs Symbol for MANUFACTURER Symbol for DATE OF MANUFACTURE Attention, consult instructions for use Attention, consulter le manuel d utilisation Type BF applied part (Safety degree specified by IEC 6060-) Partie appliquée de type BF (niveau de sécurité spécifié par la norme CEI 6060-) Symbol for Authorised Representative in the European Union この CE マーキングは EC 指令への適合宣言マークです The CE marking assures that this product complies with the requirements of the EC directive for safety. Das CE Zeichen garantiert, daß dieses Produkt die in der EU erforderlichen Sicherheitsbestimmungen erfüllt. Le logo CE certifie que ce produit est conforme aux normes de sécurité prévues par la Communauté Européenne. II marchio CE assicura che questo prodotto è conforme alle direttive CE relative alla sicurezza. La marca CE asegura que este producto cumple todas las directivas de seguridad de la CE.

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5 TABLE OF CONTENTS NOMENCLATURE... Video Duodenoscopes... PROCEDURE FLOWCHART...3 CARE AFTER USE General Application Important Instructions Internal Channels of Video Duodenoscope Endoscope Pre-Cleaning Leak Testing Cleaning High-Level Disinfection Sterilization Endoscope components and accessories Cleaning High-Level Disinfection Sterilization...48 General Endoscope components and accessories 2 POST REPROCESSING AND STORAGE SERVICING APPENDIX PENTAX Medical Compatible Reprocessing Systems/Agents...53 Reprocessing procedures of Video Duodenoscope Model ED-3490TK address the following internal channel systems. Video Duodenoscopes Suction Channel Air/Water Feeding Channel ED-3490TK Y Y Y N : YES : NO

6 NOMENCLATURE Video Duodenoscopes ED-3490TK RUBBER INLET SEAL (OF-B90) AIR/WATER FEEDING VALVE (OF-B88) SUCTION CONTROL VALVE (OF-B20) BUTTON BUTTON 2 INSTRUMENT CHANNEL INLET CONTROL BODY Alternate view BUTTON BUTTON 2 BUTTON 4 BUTTON 3 MODEL DESIGNAT UP/DOWN DEFLECTION LOCK BUTTON 4 BUTTON 3 Model Name Minimum Instrument Channel Width RIGHT/LEFT DEFLECTION LOCK Functions similar to Up/Down lock CANNULA/FORCEPS ELEVATOR CONTROL KNOB RIGHT/LEFT DEFLECTION CONTROL KNOB UP/DOWN DEFLECTION CONTROL KNOB UMBILICAL CORD STRAIN RELIEF BOOT ED-3490TK Minimum Instrument Channel Width (ID φmm) Video Duodenoscopes Minimum Instrument Channel Width (IDømm) ED-3490TK 4.2

7 DISTAL END STRAIN RELIEF BOOT INSERTION TUBE SECTION BENDING SECTION INSERTION TUBE ASSEMBLY ION AIR/WATER PORT PVE CONNECTOR Alternate view VENTING CONNECTOR VENTILATION CAP OF-C5 PVE CONNECTOR ELECTRICAL CONTACTS PVE SOAKING CAP OE-C9 Feedback Terminal LIGHT GUIDE PLUG SUCTION NIPPLE 2

8 PROCEDURE FLOWCHART Pre-Cleaning Preparation Wiping the insertion tube Aspiration of detergent solution through suction channel Flushing the air/water channel with air Transport to cleaning room Leak Testing Preparation Cleaning Cleaning the all external surfaces Brushing the suction channel and cylinder Filling the suction channel with detergent solution Soaking entire scope in detergent solution Rinsing with clean potable water Drying by wiping with a new lint-free gauze High-Level Disinfection Preparation Immersing the endoscope in disinfectant Filling channels with disinfectant Special disinfection handing procedure for elevator Soaking in disinfectant Rinsing Drying Sterilization 3

9 CARE AFTER USE -. General NOTE This Instructions for Use (IFU) has been written in accordance with 2CFR Part 80, ISO 7664, and national guidelines on reprocessing of medical products. General --. Application WARNING Reprocessing may affect device functionality. Prior to use, always inspect the endoscope, components, and accessories according to their respective IFU for proper functionality to determine that they are appropriate for patient use. Components and Accessories for Video Duodenoscopes TYPE MODEL Video Duodenoscope Name Number ED-3490TK Suction Control Valve OF-B20 Y Endoscope Component Air/Water Feeding Valve OF-B88 Y Inlet Seal OF-B90 Y Accessory Bite Block OF-Z5 Y PVE Soaking Cap OE-C9 Y Ventilation Cap OF-C5 Y Reprocessing Accessory Cleaning Adapter OF-B53 Y Cleaning Adapter OF-G7 Y Cleaning Brush CS-C9S Y Cleaning Brush CS602T Y Y N : YES : NO 4

10 --2. Important Instructions General WARNING Reusable Medical Devices that are initially supplied non-sterile require the end user to high level disinfect or sterilize them prior to initial use and to reprocess them correctly according to this IFU after each subsequent use. Proper care of the device after each clinical diagnostic or therapeutic procedure is extremely important. Immediately (within one hour) after the completion of a procedure, the endoscope, its removable components, and accessories should be precleaned and mechanically cleaned with a detergent solution specified in this IFU. Generally, if they are not precleaned within 5 minutes and mechanically cleaned within one hour after the conclusion of the procedure, dried blood, mucus, or other patient debris may cause damage to the devices or interfere with the ability of the user to properly reprocess them. The use of detergent immediately after each procedure to dissolve and remove organic contaminants and proteinaceous debris is essential to the proper care and maintenance of the endoscope. Prior to disinfection or sterilization, all instruments and components must be meticulously cleaned. Failure to do so can result in incomplete or ineffective disinfection and sterilization. Always inspect reprocessed endoscopes and accessories prior to use according to their respective Instructions for Use (IFU). WARNING are semicritical devices that require cleaning and at least highlevel disinfection. Use only legally marketed solutions and/or automated endoscope reprocessors(aers) for which efficacy validation testing including rinsing validation testing after high level disinfection with PENTAX products has been performed by their manufacturer. A list of legally marketed solutions/systems that have been determined to be materially compatible with PENTAX brand products is contained in this manual. 5

11 D R L F L U F R D D R L CAUTION During the reprocessing process, always wear protective equipment (e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross contamination. Contact the manufacturer and follow local regulations regarding safe use, appropriate handling, and disposal of cleaning and disinfection solutions, including alcohol and rinse water. Safety Data Sheets available from the cleaning and disinfection solution manufacturers should be consulted to provide guidance to end users about formulation, hazards, chemical and physical properties, first aid, handling and storage, stability, precautions, disposal, etc. To avoid damaging the endoscope, do NOT twist, rotate or excessively bend the strain reliefs [(), (2)] during inspection, clinical use, reprocessing, or any handling activity. Be particularly cautious regarding the insertion tube strain relief [()]. When wiping the insertion tube and the umbilical cord, never apply excessive force or torque to the strain reliefs, the insertion tube, or the umbilical cord. General () (2) F U F U F F Do NOT Twist or Rotate Do NOT Bend Figure.. 6

12 NOTE General This IFU contains detailed recommendations on the manual reprocessing of PENTAX endoscopes using PENTAX supplied cleaning/disinfecting adapters. AERs may also be used to reprocess flexible endoscopes. However, only those AERs should be used whose manufacturers provide device-specific instructions and have validation data to support each AER claim with respect to PENTAX instruments. AER manufacturers should be consulted for their specific claims including, but not necessarily limited to: a) the ability of the AER to provide a cleaned and high-level disinfected (or sterilized) endoscope and endoscope components (e.g., valves), b) the identification of any special feature (internal channel) or endoscope component that cannot be reprocessed and therefore requires manual reprocessing, c) the microbial quality of the rinse water, d) the inclusion of an automated alcohol rinse cycle, e) the inclusion of a terminal drying cycle that removes the majority of water from within endoscope channels, f) maintenance procedures for water filter replacement and/or decontamination of the filtration system to ensure water of suitable quality, g) compliance with local regulations and/or guidelines. NOTE PENTAX flexible endoscopes should not be exposed to temperatures in excess of 40 F (60 C) during either reprocessing or storage. NOTE All of the steps in the validated reprocessing protocol described in this manual are intended to be performed in rapid succession and as a single, continual procedure. There should be no breaks in between steps of the protocol that are of sufficient duration to permit the endoscope to dry to such an extent that dislodged debris and/or microbial contaminants would be permitted to dry onto any endoscope surface. In the event that drying of the endoscope occurs due to an excessive break in the reprocessing procedure, the procedure should be completely repeated, beginning with the first precleaning step. 7

13 --3. Internal Channels of Video Duodenoscope The following internal schematic diagram is designed to help users better understand the intricate construction of PENTAX endoscopes. Please note that all solution entrance ports and flow pathways are illustrated below. (0) (2) () (3) (7) (4) (4) (5) (6) (8) (9) () Air/WaterNozzle (2) Water Feeding Channel (3) Air Feeding Channel (4) Inlet Seal (5) Instrument Channel Inlet (6) Cleaning Adapter OF-B53 (7) Suction Channel (8) Air/Water Cylinder (9) Suction Cylinder (0) PVE Soaking Cap (ATTACH) () Ventilation Cap (REMOVE) (2) Luer-Slip Syringe with Cleaning/ Disinfecting Solution (3) Suction Nipple (4) Cleaning Adapter OF-G7 General (3) () (2) Figure..2 NOTE The elevator wire/channel is completely sealed and therefore not exposed to potential contaminants and/or patient debris. Since the elevator wire/channel is fully enclosed and not exposed to patient material, it does not require special reprocessing. However, the actual elevator mechanism (front, back and base) must be cleaned and thoroughly reprocessed. Be aware that all recessed areas around the elevator mechanism must be thoroughly cleaned using detergent solution and a cleaning brush (CS-C9S). Cleaning instructions are provided within this IFU. 8

14 -2. Endoscope Video Duodenoscope ED-3490TK can be subjected to the following cleaning, disinfection, and sterilization process. Cleaning Sterilization Duodenoscope High-Level Liquid Steam Model Manual Ultrasonic Disinfection Chemical Sterilization Sterilization ED-3490TK Y N Y Y N Y N : Yes : No -2-. Pre-Cleaning WARNING During reprocessing, always wear protective equipment (e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross contamination. Pre-cleaning is intended to remove visible debris from the endoscope immediately after its withdrawal from the patient, in order to increase the effectiveness of the subsequent cleaning procedure. are generally soiled with debris such as blood, tissues, and mucus when they are withdrawn from a patient. When such debris dries, it cannot be adequately removed in the subsequent cleaning procedure. It should be noted that pre-cleaning cannot substitute for the mechanical cleaning process. Always mechanically clean the endoscope after precleaning. During pre-cleaning, never wipe the insertion tube with alcohol or disinfecting solution. These solutions may fix organic contaminants and proteinaceous debris to the instrument and have an adverse effect on endoscope functionality and proper reprocessing. When using detergent, use only legally marketed brands that have been tested and found to be materially compatible by PENTAX (see APPENDIX). When injecting detergent solution through an internal channel, ensure that the solution exits freely from the endoscope distal end. If not, the channel might be blocked. Never use an endoscope with a blocked channel. Contact your local PENTAX facility to arrange for repair of the device. CAUTION Immediately after use, the metal light guide plug and electrical contacts/ pins of the endoscope may be HOT. To avoid burns, do not touch these areas immediately after use. For safer handling after a procedure, grasp the PVE connector housing. In order to prevent damage to the endoscope, do not place any removable components other than the items described in section -2-- of this Instructions for Use in the container used to transport the endoscope. In order to avoid damaging the endoscope, never subject it to suction in excess of 66kPa (9.57psi). 9

15 NOTE If the use of detergent solution is not permitted in the clinical procedure room, remove the endoscope from the procedure room and perform precleaning immediately in the reprocessing area Items required Endoscope component Inlet seal (OF-B90) Suction control valve (OF-B20) Air/water feeding valve (OF-B88) Other equipment Protective equipment such as gloves, gowns, face masks, etc., to minimize the risk of cross contamination. Detergent solution, Endozime (Ruhof Corporation) Water bottle and Video processor External suction source 500 ml basin Lint-free gauze 50 ml luer slip plastic syringe Preparation ) Wear personal protective equipment. 2) Prepare and fill a 500 ml basin with 400 ml ml of detergent solution per manufacturer's instructions (temperature, concentration). In the case of Endozime, add 30 ml of Endozime concentrate to 3.8 L ( gallon) of clean potable water at 20 C~30 C (68 F~86 F) Wiping the insertion tube and flushing the elevator The term Lower Position used in this document is depicted in Figure.2. Always be sure to visually check elevator positioning. Do not depend solely upon the operation and/ or position of the elevator control lever. Lower Position Figure.2. 0

16 F D R L U ) Turn off the lamp switch of the processor used for the duodenoscope. 2) Set the elevator to Lower Position by operating the elevator control lever on the control body. 3) Immediately after removing the endoscope from the patient, gently wipe the entire length of the insertion tube from control body to distal end three times using lint-free gauze soaked with detergent solution. Figure.2.2 4) Place the distal end of endoscope into a basin. 5) While the elevator is lowered, using a 50 ml syringe filled with detergent, spray 50 ml of detergent onto the rear of the elevator chamber. Figure Aspirating detergent solution through the suction channel ) Attach inlet seal (OF-B90) and suction control valve (OF-B20) to the endoscope. 2) Connect suction tube from external suction source to the endoscope suction nipple. () () Suction Tube (2) Suction Nipple (2) Figure.2.4 3) Turn on the external suction source.

17 4) Place the distal end of endoscope into a basin, and aspirate the detergent solution through the suction channel by pressing suction control valve (OF-B20) for 0 seconds. (2) () () OF-B90 (2) OF-B20 (3) Detergent Solution (3) Figure.2.5 5) Remove the distal end from the detergent solution, and press the suction control valve (OF-B20) for 0 seconds. 6) Turn off the external suction source. 7) Disconnect the suction tube from the endoscope suction nipple Flushing air/water channel with air ) Attach inlet seal (OF-B90) and air/water feeding valve (OF-B88) to the endoscope 2) Connect the air/water feeding tube of the water bottle to the endoscope air/water port. () () Air/water Feeding Tube (2) Air/water Port (2) Figure.2.6 3) Place the distal end of endoscope into a basin. 4) Set the lever on the water bottle to the drain position. 2

18 5) With the air pump of video processor ON and set to the HIGHEST pressure setting, flush the air channel with air by covering the top of air/water feeding valve (OF-B88) for 0 seconds. Then, discharge all water in the water channel by pressing the button of air/water feeding valve (OF-B88) for 0 seconds. (2) () () OF-B90 (2) OF-B88 Figure.2.7 6) Turn off the air pump of the video processor, and disconnect the air/water feeding tube of the water bottle from the endoscope air/water port Transport to cleaning room ) Turn off the power of the video processor, and detach the endoscope PVE connector from the video processor. 2) Transport the pre-cleaned endoscope to the cleaning room in a closed container. 3

19 -2-2. Leak Testing Before reprocessing and/or immersion in any fluids, PENTAX endoscopes should be tested for the loss of integrity in their watertight construction by using either PENTAX brand leakage testers (SHA-P2 or SHA-P5) or a leakage tester that is sold by PENTAX. For specific details on PENTAX leak detection procedures, please refer to the instructions supplied with PENTAX leakage testers or a leakage tester that is sold by PENTAX. CAUTION Various types of manual and automated endoscope leakage testers exist. Some are stand-alone units, and others may be integrated into an AER. PENTAX does not evaluate leakage testers that are not sold by PENTAX to verify their specific product claims with respect to their effectiveness to accurately detect leaks and/or their compatibility with PENTAX endoscopes. Insufficient pressures may reduce the likelihood of accurate leak detection, especially if the endoscope s distal bending section is not flexed during testing. Also, excessive pressures may adversely affect the endoscope, especially if pressurization occurs during automated reprocessing at elevated temperatures. PENTAX accepts no responsibility for use of leakage testers that it does not sell. Users should check with the leakage tester manufacturer and confirm their specific product claims, including compatibility with PENTAX endoscopes at various temperatures and their ability to detect leaks with/ without fluid immersion and with/without flexing of the endoscope s distal bending section. 4

20 -2-3. Cleaning WARNING During reprocessing, always wear protective equipment (e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross contamination. In order to ensure thorough cleaning, be sure to perform all cleaning steps. The effectiveness of each cleaning step will influence the effectiveness of subsequent steps. Failure to properly follow the cleaning steps described may result in incomplete or ineffective cleaning, disinfection and/or sterilization of the endoscope and/or endoscope components and accessories, resulting in a potential risk of cross-contamination. Immediately (within one hour) after the completion of a procedure, the endoscope and its components should be thoroughly and carefully cleaned with detergent solution. If the endoscope and its components are left uncleaned for an excessive time after use, dried blood, mucus or other patient debris may cause damage or interfere with the ability of the user to properly reprocess the device. For cleaning, use only legally marketed detergents that have been tested according to the instructions of the manufacturer and found to be materially compatible by PENTAX (see APPENDIX). Fresh detergent solution must be used for each endoscope that is reprocessed. After using operational/cleaning accessories (e.g., forceps,needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel. Furthermore, ensure that any therapeutic devices (e.g., clips, stents, etc.) passed through the channel are accounted for after use. If the channel becomes blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. In such a case, contact your local PENTAX Medical service facility to have the endoscope repaired. The use of an endoscope with a blocked internal channel may result in ineffective reprocessing and/or introduction of debris and/or device components into a patient during a subsequent procedure, posing a risk of cross-contamination. CAUTION PVE soaking cap (OE-C9) must be properly secured over the electrical contacts. Failure to do so can result in water invasion and damage to the endoscope. If an endoscope is cleaned without the PVE soaking cap attached, do not use the endoscope, and contact your local PENTAX service facility or sales representative. The ventilation cap (OF-C5) must be taken OFF during reprocessing. Failure to do so can result in damage to the endoscope. If an endoscope is cleaned with the ventilation cap attached, do not use the endoscope, and contact your local PENTAX service facility or sales representative. During cleaning, never twist, rotate, or bend the insertion portion and umbilical cord excessively. Never subject the endoscope to ultrasonic cleaning methods. In order to prevent damage to the endoscope, do not place any objects other than the reprocessing accessories listed in section of this Instructions for Use with the endoscope when immersing the endoscope in a cleaning basin. 5

21 Items required Endoscope component Inlet seal (OF-B90) Reprocessing accessory PVE soaking cap (OE-C9) Cleaning brush (CS602T) Cleaning brush (CS-C9S) Cleaning Adapter (OF-B53) Cleaning Adapter (OF-G7) Other equipment Protective equipment such as gloves, gowns, face masks, etc., to minimize the risk of cross contamination. Detergent solution, Endozime (Ruhof Corporation) Clean potable water Basin sufficient in size to immerse the entire endoscope (at least 50 cm in length x 40 cm in width x 5 cm in depth, or 9.7 inches in length x 5.8 inches in width x 5.9 inches in depth) Lint-free gauze 50 ml luer slip plastic syringe Preparation ) Wear personal protective equipment. 2) Attach PVE soaking cap (OE-C9) to the endoscope. 3) Detach ventilation cap (OF-C5) from the endoscope. (2) () OE-C9 (2) OF-C5 () Figure.2.8 4) Fill a basin with a sufficient volume of detergent solution to completely immerse the endoscope. Prepare the detergent in accordance with the manufacturer s instructions (temperature, concentration). In the case of Endozime, add 30 ml of Endozime concentrate to 3.8 L ( gallon) of clean potable water at 20 C~30 C (68 F~86 F). 6

22 Cleaning all external surfaces CAUTION Do not squeeze or severely bend the insertion tube. Do not use any abrasive materials. Be careful to avoid damage to the distal lenses. The terms Lower Position and Upper Position" used in this document are depicted in Figure.2.9. Always be sure to visually check elevator positioning. Do not depend solely upon the operation and/or position of the elevator control lever. Lower Position Upper Position Figure.2.9 ) Fully immerse the endoscope with the components attached in the detergent solution. 2) Detach inlet seal (OF-B90), suction control valve (OF-B20), and air/water feeding valve (OF-B88) from the endoscope. Open the cap of inlet seal (OF-B90) in the detergent solution. (2) (3) () () OF-B90 (2) OF-B20 (3) OF-B88 Figure.2.0 3) Suction control valve (OF-B20) and air/water feeding valve (OF-B88) are reprocessed separately from endoscope. (see Section -3 Endoscope components and accessories ) 4) While still immersed in the detergent solution, wipe the entire surface of endoscope and inlet seal (OF-B90) two times in one direction with a lint-free gauze. 7

23 Brushing and flushing of Elevator 5) Set the elevator to the Upper Position by operating the elevator control lever on the control body. 6) Hold cleaning brush (CS-C9S) with fingers on brush shaft near the small brush head. 7) Perform steps a) through c) in order to brush the front of elevator chamber and elevator recess area with cleaning brush (CS-C9S). Repeat nine more times (total ten times). a) Place the smaller brush head of cleaning brush (CS-C9S) underneath the front opposite of lens side of the elevator chamber. b) Brush to the lens side. c) Brush to the front scraping out the debris in the lens side corner and wall of the elevator chamber. c b a Figure.2. 8) Clean the debris from the brush head by rubbing with fingers. 9) Similarly perform step a) through c) in order to brush from the front lens side. Repeat nine more times. (total ten times) a) Place the smaller brush head of cleaning brush (CS-C9S) underneath the front lens side of the elevator chamber. b) Brush to the opposite of lens side. c) Brush to the front scraping out the debris in the front opposite of lens side corner and wall of the elevator chamber. a b b Figure.2.2 0) Clean the debris from the brush head by rubbing with fingers. 8

24 ) While the elevator is raised, place the smaller brush head of cleaning brush (CS-C9S) into the space behind the elevator. Brush to the front scraping out the debris in the back of the elevator. Repeat nine times. (total ten times) Back Figure.2.3 2) Clean the debris from the brush head by rubbing with fingers. 3) While the elevator is raised, place the smaller brush head of cleaning brush (CS-C9S) into the front area of elevator chamber. Brush to the front scraping out the debris in the back of the front area of elevator chamber. Repeat nine times. (total ten times) Front Figure.2.4 4) Clean the debris from the brush head by rubbing with fingers. 5) While the elevator is raised, using a 50 ml syringe filled with detergent solution without air, spray 50 ml of detergent onto the front of the Elevator Chamber. Figure.2.5 9

25 6) Set the elevator to Lower Position by operating the elevator control lever on the control body. 7) Perform steps a) through c) in order to brush the back area of elevator chamber and elevator recess area with cleaning brush (CS-C9S). Repeat nine more times (total ten times). a) Place the smaller brush head of cleaning brush (CS-C9S) into the opposite side of lens side of the back area of elevator chamber. b) Brush to the lens side. c) Brush to the front scraping out the debris in the right corner of the back area of elevator chamber. c b a Figure.2.6 8) Similarly perform steps a) through c) in order to brush from the lens side. Repeat nine more times. (total ten times) a) Place the smaller brush head of cleaning brush (CS-C9S) underneath the lens side of the back of elevator chamber. b) Brush to the opposite of lens side. c) Brush to the front scraping out the debris in the opposite of lens side corner and wall of the back area of elevator chamber. a b c Figure

26 9) Place the smaller head of cleaning brush (CS-C9S) on the elevator. In order to clean the upper surface of the elevator, brush back and forth ten times. Figure ) While the elevator is lowered, using a syringe filled with detergent without air, spray 50 ml of detergent onto the rear of the elevator chamber. Figure.2.9 2) Visually inspect the entire surface of the endoscope to insure that no soil is present, paying special attention to areas such as the distal end, elevator, elevator chamber, and control body, which are the most likely regions to retain visible soil. Figure ) If any soil is still present on the distal end and control body, use cleaning brush (CS-C9S) to gently brush until all soil has been removed. 23) If any soil is still present on the elevator and elevator chamber, repeat steps 5-20 until all soil has been removed. 2

27 Brushing the suction channel and cylinder WARNING Do not use cleaning brushes other than those specified in this instruction for use. Failure to do so can result in endoscope damage or incomplete or ineffective cleaning. Cleaning brush (CS602T) is provided non-sterile for one time use. Never reuse the brush on more than one instrument. Prior to use, ensure that cleaning brushes are not damaged (e.g., kinked shaft or bent or missing bristles). In order to prevent the dissemination of patient debris left in the endoscope channel into the environment, always withdraw brushes slowly. CAUTION In order to avoid damage to the endoscope distal end, never attempt to insert a cleaning brush into the endoscope distal tip. Do not insert cleaning brush (CS602T) into the suction control valve cylinder. The brush head of cleaning brush (CS602T) could become stuck within the suction control valve cylinder. Never apply excessive pressure to introduce or withdraw the brush. This can result in damage to the endoscope and/or the brush. Some manufacturers cleaning brushes/devices have been found to damage PENTAX endoscopes and/or create the need for service, as they can become lodged ( stuck ) inside various lumens of PENTAX endoscopes. The likelihood of endoscope damage or servicing increases if a cleaning device does not have a protective tip (or contains any sharpedged surface), if its flexible shaft uses a flimsy plastic material that is not firm enough to allow for easy accessory advancement, and/or if the proper sequence and/or direction of channel cleaning is not followed as described in the PENTAX IFU. To prevent excessive friction between brush and channel, do NOT tightly coil the insertion tube and umbilical cord to a diameter of less than 30cm. NEVER attempt to pass the cleaning brush through a fully angulated endoscope. Failure to follow these instructions can result in endoscope or brush damage. 22

28 Suction channel cleaning ) Insert the large brush head of cleaning brush (CS-C9S) into the instrument channel inlet until it cannot be advanced further. Repetitively move the brush back and forth while twisting it left and right for 0 seconds in order to scrub the entire inner surface of the instrument channel inlet. () (2) () CS-C9S (2) Instrument Channel Inlet Figure.2.2 2) Withdraw cleaning brush (CS-C9S) from the inlet, and clean the debris from the brush head by rubbing with fingers. 3) Insert the blue tip of cleaning brush (CS602T) into the opening of the suction nipple, and gently pass the brush until it appears in the suction cylinder. (3) () CS602T (2) Suction Nipple (3) Suction Cylinder (2) () Figure ) Grasp the blue tip of the brush shaft, and gently pull the brush from the suction cylinder until the brush heads exit the suction cylinder. Clean debris from the brush head by rubbing with fingers. 23

29 5) Insert the blue tip of cleaning brush (CS602T) into the opening at the bottom of the suction cylinder on the control head, and gently advance the brush until it exits the distal end of the endoscope. () (2) () CS602T (2) Suction Cylinder (3) Distal End (3) Figure ) Grasp the blue tip of the brush shaft, and gently pull the brush from the distal end of the endoscope until the brush heads exits the distal end. Clean debris from the brush head by rubbing with fingers. Cylinder cleaning 7) Insert the large brush head of cleaning brush (CS-C9S) into the suction cylinder until it cannot be advanced further. Repetitively move the brush back and forth while twisting it left and right for 0 seconds in order to scrub the entire inner surface of the cylinder. () () CS-C9S (2) Suction Cylinder (2) Figure ) Withdraw the brush from the cylinder, and clean debris from the brush head by rubbing with fingers. 24

30 9) Insert the large brush head of cleaning brush (CS-C9S) into the air/water cylinder until it cannot be advanced further. Repetitively move the brush back and forth while twisting it left and right for 0 seconds in order to scrub the entire inner surface of the cylinder. () () CS-C9S (2) Air/water Cylinder (2) Figure ) Withdraw the brush from the cylinder, and clean debris from the brush head by rubbing with fingers. ) After brushing the endoscope, dispose of cleaning brush (CS602T), which is a single-use accessory Filling the channel with detergent solution WARNING While injecting detergent solution through the channels, avoid the introduction of air. The presence of air bubbles can prevent contact of the detergent solution with channel surfaces. Always fully immerse the endoscope while flushing detergent solution into the endoscope channel. It is imperative that the cleaning adapter (OF-B53) be securely attached to the endoscope. Failure to properly connect and secure the cleaning adapter can result in ineffective and incomplete reprocessing. CAUTION In order to avoid damage to the endoscope, never apply excessive force if resistance is encountered while flushing the detergent solution into the channels. Always immerse the endoscope, components, and accessories completely in the detergent solution during cleaning. 25

31 Attaching components and accessories to the endoscope ) Follow the steps below in order to attach cleaning adapter (OF-B53) to the air/ water cylinder and suction cylinder. This adapter (seals) the air/water and suction cylinders to permit unidirectional flow of solution through these delivery/aspiration systems. [a] Raise the locking cap and slide the side covers (marked with ) downward. [b] Align the cylinder guide over the air/water and suction cylinder ports. [c] Slide the cleaning adaptor (OF-B53) forward. [d] Holding the side covers (marked with ), push down and slide the locking cap under the locking tab to secure. [e] Secure the locking cap with the locking tab on the base. [a] () (2) () Rubber Seal (2) Locking Cap (3) Base (3) [b] (2) () Cylinder Guide (2) Cylinder Ports (3) Cylinder Inlets () (3) [c] [d] (2) () End of Locking Cap (2) Locking Tab () [e] () Locking Tab () () Figure

32 2) Attach inlet seal (OF-B90) and cleaning adapter (OF-G7) to the endoscope. () (2) () OF-B53 (2) OF-B90 (3) OF-G7 (3) Figure.2.27 Filling channels with detergent solution 3) Attach a 50 ml syringe filled with the detergent solution without air to cleaning adaptor (OF-G7), and inject 250 ml of the detergent solution into the air/water channel. () OF-G7 () Figure ) Check to confirm that detergent solution flows out from the air/water nozzle(s) on distal end. 5) Attach a 50 ml syringe filled with detergent solution without air to the suction nipple, and inject 350 ml of the detergent solution into the suction channel. () Suction Nipple () Figure

33 6) Attach a 50 ml syringe filled with detergent solution without air to the inlet seal (OF-B90), and inject 50 ml of detergent solution into the suction channel. () () OF-B90 Figure ) Check to confirm that detergent solution flows out from the suction channel opening on the distal end. 8) After injecting detergent solution into all channels, detach inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) from the endoscope, and leave them to soak along with the endoscope in the detergent solution until the next step. Open the cap of inlet seal (OF-B90). () (2) () OF-B53 (2) OF-B90 (3) OF-G7 (3) Figure

34 Soaking in detergent solution WARNING The detergent solution must remain in contact with ALL internal channels, external endoscope surfaces, and components for the time period recommended by the manufacturer of the detergent. During immersion, detach all components and accessories (except the soaking cap) from the endoscope to ensure contact of all endoscope surfaces with the detergent solution. Avoid introduction of air during the flushing process. Confirm that no air bubbles exit from the channel openings at the endoscope distal tip. The presence of the air bubbles can prevent contact of the detergent with channel surfaces. CAUTION NEVER subject the endoscope to an ultrasonic cleaning method. ) While fully immersing the endoscope, inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF-G7), ensure that there are no air bubbles on all external surfaces. If any air bubbles are detected, flush them away with detergent solution using a 50 ml syringe. 2) Soak the endoscope, inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF-G7) under conditions (temperature, concentration, time) specified by the detergent manufacturer. In the case of Endozime, the soaking time is 3 minutes. Figure.2.32 Purging detergent solution from all channels 3) After soaking, attach inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) to the endoscope, and close the cap of inlet seal (OF-B90). (see Figure.2.27, p27) 4) Attach a 50 ml syringe filled with air to cleaning adapter (OF-G7), and flush the air/water channel with 250 ml of air to purge residual detergent solution. (see Figure.2.28, p27) 5) Attach a 50 ml syringe filled with air to the suction nipple, and flush the suction channel with 350 ml of air to purge residual detergent solution. (see Figure.2.29, p27) 6) Attach a 50 ml syringe filled with air to the inlet seal (OF-B90), and flush the suction channel with 50 ml of air to purge residual detergent solution. (see Figure.2.30, p28) 7) Remove the endoscope (with inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) attached) from the detergent solution. 29

35 Rinsing WARNING It is important that all internal channels, external endoscope surfaces, and components be thoroughly rinsed with clean water to remove residual detergent solution. Failure to do so can result in ineffective or incomplete disinfection and sterilization. First rinse ) Place the endoscope, inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF- G7) into a basin of clean potable water that is of sufficient volume to completely immerse the endoscope. 2) Detach inlet seal (OF-B90) and cleaning adapters (OF-B53, and OF-G7) from the endoscope (see Figure.2.3, p28). Open the cap of inlet seal (OF-B90). 3) Wipe all exterior surfaces of the endoscope, inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF-G7) two times with a lint-free gauze in order to remove residual detergent solution. 4) While still completely immersed in clean potable water, grasp the distal end, control body of endoscope, and PVE connector with two hands, and agitate it under the clean potable water by moving it from side to side repeatedly for 20 seconds. Figure ) Grasp inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) with a hand, and agitate them under the clean potable water by moving them from side to side repeatedly for 20 seconds. 6) Attach inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) to the endoscope, and close the cap of inlet seal (OF-B90). (see Figure.2.27, p27) 7) Attach a 50 ml syringe filled with clean potable water without air to cleaning adapter (OF-G7), and flush the air/water channel with 250 ml of water. (see Figure.2.28, p27) 8) Attach a 50 ml syringe filled with clean potable water without air to the suction nipple, and flush the suction channel with 350 ml of water. (see Figure.2.29, p27) 9) Attach a 50 ml syringe filled with clean potable water without air to the inlet seal (OF- B90), and flush the suction channel with 50 ml of water. (see Figure.2.30, p28) 0) Remove the endoscope (with inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) attached) from the clean potable water. 30

36 ) Attach a 50 ml syringe filled with air to cleaning adapter (OF-G7), and flush the air/water channel with 250 ml of air. (see Figure.2.28, p27) 2) Attach a 50 ml syringe filled with air to the suction nipple, and flush the suction channel with 350 ml of air. (see Figure.2.29, p27) 3) Attach a 50 ml syringe filled with air to the inlet seal (OF-B90), and flush the suction channel with 50 ml of air. (see Figure.2.30, p28) Second rinse 4) Fill a basin with clean potable water, and repeat steps - 3 in order to perform a second complete rinse. 5) Detach inlet seal (OF-B90) and cleaning adapters (OF-B53 and OF-G7) from the endoscope. (see Figure.2.3, p28) Drying ) Gently wipe and dry all external surfaces of the endoscope, inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF-G7) with a new lint-free gauze Visual inspection NOTE Ideally, work surfaces used for inspection require,000-2,000 lux illumination (ANSI/AMMI ST79). ) Under adequate lighting, visually inspect the entire surface of the endoscope and accessories to insure that no debris is present, paying special attention to the surfaces of the duodenoscope elevator, recessed areas around the elevator, and the surfaces of the elevator chamber. If any soil is still present on the duodenoscope and accessories, remove it by wiping and/or brushing the area(s) in question in detergent solution with lint-free cloths and/or the appropriate brush(es) specified in this IFU until it has been completely removed. After complete removal of residual soil has been attained, perform all rinsing steps that normally follow cleaning. 3

37 -2-4. High-Level Disinfection Prior to high-level disinfection, the end user should confirm that the high level disinfectant concentration is greater than the minimum effective concentration (MEC) of reused disinfectant as specified in the manufacturer s instructions. WARNING During the reprocessing process, always wear protective equipment (e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross contamination. Prior to disinfection, it is imperative that any solutions previously used in the cleaning process be thoroughly rinsed and dried. Failure to do so can result in ineffective or incomplete disinfection. For high-level disinfection, use an appropriate disinfecting solution according to the instructions of the disinfectant s manufacturer (temperature, concentration, time). Adhere to the instructions to accomplish effective and complete disinfection. The endoscope may be damaged if exposed to a disinfectant under conditions other than those specified by the disinfectant manufacturer. Use only a legally marketed disinfectant that has been tested according to the instructions provided by the disinfectant manufacturer and found to be materially compatible by PENTAX. It is imperative that ALL internal surfaces of the channels be in contact with the disinfecting solution for the time period and at the temperature recommended by the manufacturer of the disinfectant. Ideally, all final rinses should be performed with sterile water, clean potable water, or water that meets the requirements of the health care facility. Regardless of the quality of the rinse water used, it is essential to perform a final alcohol rinse followed by forced air in order to completely dry the endoscope channels and prevent bacterial colonization and/or infections associated with waterborne microorganisms. The basin that is used to perform disinfectant immersion should be thoroughly cleaned prior to filling it with disinfectant solution. Prior to disinfection, the endoscope and accessories must be meticulously cleaned. Failure to do so can result in incomplete or ineffective disinfection. CAUTION Prior to high level disinfection, attach PVE soaking cap (OE-C9). Failure to do so can result in water invasion and damage to the endoscope. If the endoscope is disinfected without the PVE soaking cap attached, do not use the endoscope, and contact your local PENTAX service facility or sales representative. Prior to disinfection, detach the ventilation cap (OF-C5). Failure to do so can result in damage to the endoscope. If the endoscope is disinfected with the ventilation cap attached, do not use the endoscope, and contact your local PENTAX service facility or sales representative. During disinfection, never twist, rotate or bend the insertion tube and umbilical cord excessively. In order to prevent damage to the endoscope, do not place any objects other than the reprocessing accessories described in section of this Instructions for Use with the endoscope when immersing it in the disinfection basin. 32

38 Items required Endoscope component Inlet seal (OF-B90) Reprocessing accessory PVE soaking cap (OE-C9) Cleaning adapter (OF-B53) Cleaning adapter (OF-G7) Other equipment Protective equipment such as gloves, gowns, face masks, etc., to minimize the risk of cross contamination. Disinfecting solution, CIDEX Activated Dialdehyde Solution (Johnson & Johnson) Sterile water (preferred) or clean potable water 70-90% medical grade ethyl or isopropyl alcohol Basin sufficient in size to immerse the entire endoscope (at least 50 cm in length x 40 cm in width x 5 cm in depth, or 9.7 inches in length x 5.8 inches in width x 5.9 inches in depth). Sterile gauze 50 ml luer slip syringe Preparation ) Wear personal protective equipment. 2) Attach PVE soaking cap (OE-C9) to the endoscope. 3) Ensure that ventilation cap (OF-C5) is detached from the endoscope. (2) () OE-C9 (2) OF-C5 () Figure ) Prepare a basin of sufficient volume capacity to fully immerse the endoscope with CIDEX Activated Dialdehyde Solution in accordance with the disinfectant manufacturer s instructions for concentration and temperature Immersing the endoscope in disinfecting solution ) Fully immerse the endoscope, inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF-G7) in the disinfecting solution. Open the cap of inlet seal (OF-B90). 2) Wipe all external surfaces of the endoscope with a sterile gauze two times in order to thoroughly contact disinfecting solution to the surfaces. Ensure that all surfaces are in contact with disinfecting solution. 33

39 3) Lower the elevator by operating the elevator control lever on the control body Filling the channel with disinfecting solution WARNING When filling endoscope channels with disinfectant, avoid the introduction of air. The presence of air bubbles can prevent contact of the disinfectant with channel surfaces. Avoid introduction of air during the flushing process. Confirm that no air bubbles exit from the channel openings at the endoscope distal tip. The presence of the air bubbles can prevent contact of the disinfectant with channel surfaces. Always immerse the endoscope while filling endoscope channels with disinfectant. The terms Lower Position, Middle Position, and Upper Position" used in this document are depicted in Figure.2.35 Always be sure to visually check elevator positioning. Do not depend solely upon the operation and/or position of the elevator control lever. Lower Position Middle Position Upper Position Figure.2.35 Always immerse the endoscope, components, and accessories in disinfecting solution during disinfection. ) Attach inlet seal (OF-B90), and cleaning adapters (OF-B53 and OF-G7) to endoscope, and close the cap of inlet seal (OF-B90). () (2) () OF-B53 (2) OF-B90 (3) OF-G7 (3) Figure